The NEUROlogically-impaired Extubation Timing Trial (NEURO-ETT)

Sunnybrook Health Sciences Centre

Status: Unknown

Conditions: Acute Brain Injury

Treatments: Procedure: Usual Care; Procedure: Airway Management Pathway

Study type: Interventional

Funder types: Other

Identifiers

NCT04291235

NEURO-ETT

Details and patient eligibility

About

This trial in brain-injured patients will test which of the following will lead to better patient outcomes: (1) an airway management pathway consisting of daily assessments and removal of the breathing tube as soon as patients can breathe on their own and appear able to protect their airway; versus (2) the usual treatment patients would have received if they were not enrolled in this trial.

Full description

Thousands of patients suffer severe brain injuries every year, from causes such as trauma, stroke, and infection. These patients are usually not fully awake and need help with their breathing and with preventing them from choking on their secretions. This is done with a breathing tube inserted through the mouth into the lungs and connected to a breathing machine. As patients recover, It is often unclear when the best time is to remove the breathing tube. Doctors might decide to remove it relatively early, or they may wait until the patient is more fully awake, or they may perform a tracheostomy (neck surgery to insert a new tube directly into the windpipe (trachea), replacing the temporary breathing tube). Each of these approaches has risks and benefits. This trial in brain-injured patients will test which of the following will lead to better patient outcomes: (1) an airway management pathway consisting of daily assessments and removal of the breathing tube as soon as patients can breathe on their own and appear able to protect their airway; versus (2) the usual treatment patients would have received if they were not enrolled in this trial.

Enrollment: 332 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age > 16 years
2. Acute brain injury (subarachnoid hemorrhage, diffuse axonal injury, ischemic stroke, intracerebral hemorrhage, brain tumor, global cerebral anoxia/cardiac arrest, meningitis/encephalitis, cerebral abscess, epidural hematoma, subdural hematoma, seizure) that occurred within the previous 4 weeks
3. Receiving mechanical ventilation via endotracheal tube for ≥ 48 hours

Exclusion criteria

1. Quadriplegic
2. Neuromuscular disease that will result in prolong need for mechanical ventilation, including but not limited to Guillain-Barre syndrome, cervical spinal cord injury, advanced multiple sclerosis
3. Do-Not-Reintubate order in place
4. Previously randomized in this trial
5. Underlying pre-existing condition with life expectancy less than 6-months
6. Current enrolment in an RCT that precludes NEURO-ETT co-enrollment

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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332 participants in 2 patient groups

Airway Management Pathway

Active Comparator group

Description:

An airway management pathway consisting of daily assessments and removal of the breathing tube as soon as patients can breathe on their own and appear able to protect their airway

Treatment:

Procedure: Airway Management Pathway

Usual Care

Active Comparator group

Description:

The usual clinical practice is often to keep the patient on artificial respiration for longer in the hope that the patient will wake up before removing the tube, or performing a tracheostomy if the patient doesn't wake up

Treatment:

Procedure: Usual Care